CERAVE DEVELOPED WITH DERMATOLOGISTS HEAL AND PROTECT BALM- dimethicone stick 
L'Oreal USA Products Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient

Dimethicone 1%

Purpose

Skin protectant

Uses

  • temporarily protects and helps relieve chafed, chapped or cracked skin
  • helps protect from the drying effects of wind and cold weather

Warnings

For external use only

When using this product

do not get into eyes

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

apply as needed

Inactive ingredients

paraffin, ethylhexyl palmitate, petrolatum, butyrospermum parkii (shea) butter, ozokerite, euphorbia cerifera (candelilla) wax, cetyl alcohol, glycerin, tocopheryl acetate, ceteareth-25, behenic acid, cholesterol, ceramide 1, ceramide 3, ceramide 6-II, ceramide EOS, ceramide NS, caprooyl phytosphingosine, caprooyl sphingosine, ascorbyl palmitate, water, BHT, sodium hyaluronate

Questions or comments?

Toll-free number 1-888-768-2915

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CERAVE DEVELOPED WITH DERMATOLOGISTS HEAL AND PROTECT BALM 
dimethicone stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-301
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PARAFFIN (UNII: I9O0E3H2ZE)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
PETROLATUM (UNII: 4T6H12BN9U)  
SHEA BUTTER (UNII: K49155WL9Y)  
CERESIN (UNII: Q1LS2UJO3A)  
CANDELILLA WAX (UNII: WL0328HX19)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CETEARETH-25 (UNII: 8FA93U5T67)  
BEHENIC ACID (UNII: H390488X0A)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
CERAMIDE 1 (UNII: 5THT33P7X7)  
CERAMIDE 3 (UNII: 4370DF050B)  
CERAMIDE 6 II (UNII: F1X8L2B00J)  
CERAMIDE EOS (UNII: CR0J8RN66K)  
CERAMIDE NG (UNII: C04977SRJ5)  
N-HEXANOYLSPHINGOSINE (UNII: 038753E78J)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
WATER (UNII: 059QF0KO0R)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-301-0142.5 g in 1 CONTAINER; Type 0: Not a Combination Product10/01/201701/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/01/201701/01/2022
Labeler - L'Oreal USA Products Inc (002136794)

Revised: 1/2020
Document Id: 260fc7de-a719-4016-936e-5ae711bb16a0
Set id: 4ef0fa76-9050-4112-9a07-802d6084c0e6
Version: 3
Effective Time: 20200102
 
L'Oreal USA Products Inc